drugset / Trial / NCT04231292
A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
RandomizedParallel-groupSingle-blindTreatment
Summary
A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
Timeline
- Start
- 2020-03-01
- Primary completion
- 2020-06-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RD01 | Protein / enzyme biologic | 0.8 ug/kg | Subcutaneous |
| Subject | RD01 | Protein / enzyme biologic | 1.2 ug/kg | Subcutaneous |
| Subject | RD01 | Protein / enzyme biologic | 1.6 ug/kg | Subcutaneous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 150 iu/kg | Subcutaneous |